Tuesday, November 26, 2013

A new study, published online ahead of print in the Journal of Adolescent Health, is being used by its authors to mislead the public into thinking that there is now evidence that electronic cigarettes are leading to smoking initiation and addiction among adolescents.

In a statement accompanying the study, study author Stanton Glantz proclaims that electronic cigarettes are "a new route to smoking addiction for adolescents."

He also represents his data as showing that: "kids who use e-cigs are less likely to have stopped smoking."

Glantz writes: "Use of e-cigarettes is associated with heavier use
of conventional cigarettes, which raises the likelihood that actual use
of e-cigarettes may increase harm by creating a new pathway for youth
to become addicted to nicotine and by reducing the odds that an
adolescent will stop smoking conventional cigarettes.”"

Glantz concludes: "We are witnessing the beginning of a new phase of the nicotine epidemic and a new route to nicotine addiction for kids."

The Rest of the Story

The rest of the story is that what we are actually witnessing is not the demonstration that electronic cigarettes are a route to smoking addiction for adolescents, but the twisting, manipulation, and misrepresentation of scientific data in order to mislead the public.

The problem is that Glantz is taking results from a cross-sectional study and misrepresenting them as if they were derived from a longitudinal study. Moreover, he is failing to heed his own warning, buried in the fine print of the paper, that: "Because the [survey] used cross-sectional data, the directionality of our findings cannot be established."

By examining the two major so-called "findings" of the study, you'll be able to see how Glantz is misrepresenting the study's actual findings.

1. "Kids who use e-cigs are less likely to have stopped smoking."

This conclusion is scary, and if true, I would have to think seriously about whether to continue to support electronic cigarettes as a smoking cessation strategy. The statement suggests that in this study, smokers who used electronic cigarettes were less likely to have quit over time than smokers who did not use electronic cigarettes.

There's just one problem: this study did not follow any smokers over time.

Despite the author's insinuation that this was a longitudinal study and that smokers who used electronic cigarettes were less likely to have stopped smoking over time, the study was in fact cross-sectional. It was a snapshot of tobacco/e-cigarette use behavior at a single point in time.

In fact, it did not assess whether any of the respondents had quit smoking, because it did not determine whether youth who did not currently smoke were ever current smokers. A youth could have puffed one time on a cigarette at a party and never smoked again, yet this individual would be considered a "former smoker" in this study.

Because the study is cross-sectional, there are two - not one - potential explanations for the observed association.

One possibility is as Glantz concludes: it is possible that smokers who used electronic cigarettes were less likely to quit over time.

But there is a second possibility: it could be that kids who experimented with cigarettes but did not begin smoking were not interested in starting to use electronic cigarettes. In other words, the causation could work in the opposite direction. The reason for the observed association between the use of electronic cigarettes and a greater chance of being a current than a "former" smoker could be simply that smokers are overwhelmingly more interested in electronic cigarettes than nonsmokers.

In fact, this is quite a likely possibility, as the study reports that current smokers are 66 times more likely than never smokers to be current electronic cigarette users.

In summary, the "actual" finding of the study is that there was an association between being a current as opposed to a former smoker and using or having used electronic cigarettes. But Glantz instead reports the interpretation that he apparently "wants" to believe: that kids who use e-cigs are less likely to have stopped smoking. He fails to inform readers of the equally likely (probably more likely) possibility that electronic cigarette use simply appeals much more to smokers than to kids who are not currently smoking.

2. "Use of e-cigarettes is associated with heavier use
of conventional cigarettes, which raises the likelihood that actual use
of e-cigarettes may increase harm by creating a new pathway for youth
to become addicted to nicotine."

This conclusion is scary, and if true, I would have to think
seriously about whether to continue to support electronic cigarettes as a
smoking cessation strategy. The statement suggests that in this study,
the use of electronic cigarettes caused smokers to smoke more, thus enhancing their addiction to cigarette smoking.

There's just one problem: this study was cross-sectional so it cannot conclude whether electronic cigarette use caused kids to smoke more or whether kids who smoked more were more likely to try electronic cigarettes (perhaps because they wanted to quit or cut down).

Once again, because the study is cross-sectional, there are two - not one - potential explanations for the observed association.

One
possibility is as Glantz concludes: it is possible that the use of electronic cigarettes led smokers to significantly increase their cigarette use, and thus to enhance their nicotine and smoking addiction.

But
there is a second possibility: it could be that kids who smoked more heavily were more likely to want to try electronic cigarettes, perhaps in an attempt to quit or cut down. In other words, the causation
could work in the opposite direction. The reason for the observed
association between the use of electronic cigarettes and a greater
chance of being a heavy smoker could be simply that
heavier smokers are more interested in electronic cigarettes than
lighter nonsmokers.

In fact, this is quite a likely
possibility, as the study reports that current smokers who are trying to quit are much more likely to use electronic cigarettes.

In
summary, the "actual" finding of the study is that there was an
association between being a heavier smoker and
using electronic cigarettes. But Glantz instead reports
the interpretation that he apparently "wants" to believe: that electronic cigarettes are causing kids to smoke more. He fails to inform
readers of the equally likely (probably more likely) possibility that
electronic cigarette use simply appeals much more to heavier smokers, perhaps because they are trying to quit or cut down.

The Study Conclusion

Ultimately, the study and Glantz' statement conclude that electronic cigarettes are "a new route to smoking addiction for adolescents."

However, this is a cross-sectional study, and it did not find a single youth whostarted using electronic cigarettes and then went on to become a regular cigarette smoker.

How then, can the study conclude that youths are starting with electronic cigarettes and then going on to be addicted to smoking?

The answer is simple: it can't.

The study was cross-sectional so it cannot determine whether the dual users in the study had initiated with electronic cigarettes and then went on to smoke, or whether they initiated with smoking and then went on to try electronic cigarettes.

But that didn't stop the study authors from drawing this conclusion.

Why Continue to Do Tobacco Control Research?

As we go into the Thanksgiving holiday, I am seriously thinking about why there is a need to continue to do tobacco control research. If we are going to simply conclude what we want to conclude, regardless of the ability of the science to reach such a conclusion, then what's the point of doing the research in the first place?

A lot of money (in this case, taxpayer money) could have been saved if we had simply told Dr. Glantz: don't bother doing the study. Just come out with your pre-determined conclusion. It will save the government and the taxpayers a lot of money and you're going to reach this conclusion anyway, regardless of whether the study design allows you to draw such a conclusion.

Seriously: why not just have anti-smoking researchers save a lot of time and money by simply disseminating their conclusions about how evil electronic cigarettes are, without actually conducting the research? The money saved could go into a fund that would be used for tobacco control education and prevention programs. This would be a win-win-win. Electronic cigarette opponents could continue to disseminate their unsupported conclusions, since the actual results of these studies don't matter anyway, and as an added bonus, taxpayers save money and funds are generated to further reduce smoking rates.

The rest of the story is that the findings of this study have been misrepresented to support what appears to be a pre-determined conclusion. The study is cross-sectional, and as the authors themselves acknowledge, it does not permit the very causal conclusions that they have drawn. The scary findings about kids being less likely to quit and more likely to smoke more because of electronic cigarette use could simply be a reflection of the possibility that kids who smoke, and who smoke more heavily, are more attracted to electronic cigarettes, perhaps because they want to quit or cut down on the amount they are smoking.

Following the lead set by CDC in telling the public that electronic cigarettes are a gateway to tobacco cigarette smoking, the Cambridge (Massachusetts) Public Health Department has proclaimed that e-cigarettes "are powerfully addictive and often serve as a 'gateway' to a lifelong tobacco habit."

In a memorandum to the City Manager, the Cambridge Public Health Department writes as follows:

"The manner in which tobacco companies have targeted younger groups also poses a long-term concern, as many younger individuals may not understand that e-cigarettes are powerfully addictive and often serve as a 'gateway' to a lifelong tobacco habit."

The memorandum recommends that the city tobacco ordinance be amended to ban the sale of electronic cigarettes to minors.

The Rest of the Story

I completely agree with this policy recommendation. However, I don't believe it was necessary to rely upon a false or unsupported statement to support this recommendation.

There is, in fact, no evidence that electronic cigarettes serve as a gateway to a lifelong tobacco habit. In fact, there is not even any evidence that electronic cigarettes serve as a gateway to a short-lived tobacco habit. The only study to examine this hypothesis found that electronic cigarettes are not currently serving as a gateway to cigarette smoking among young people.

Although more research needs to be done, it is safe to say that at the present time, the evidence suggests that electronic cigarettes are not a major gateway to smoking initiation among youth. At the very least, however, it is undeniable that there is no evidence to support the assertion that electronic cigarettes are leading to smoking among youth, much less a lifelong addiction to tobacco.

The larger part of this story is the question of how the public health department came to believe that electronic cigarettes are a gateway to a lifetime of smoking.

It is possible, and in fact, likely, that this local health department was simply reiterating material that was spewed out by the CDC in a widely circulated Associated Pressstory,
which appeared in numerous newspapers and on television station sites,
Dr. Frieden was quoted as stating that electronic cigarettes are
"condemning many kids to struggling with a lifelong addiction to
nicotine." These articles also state that Dr. Frieden suggested the CDC
survey data indicate that many kids experiment with e-cigarettes and
then go on to smoke cigarettes.

It is certainly curious that the Cambridge Public Health Department's language mirrors that of Dr. Frieden.

According to the AP story: "health officials worry
e-cigarettes could re-ignite teen
cigarette use. They point to a finding in the study that 20 percent of
middle school e-cigarette users had never tried conventional cigarettes.
When the same question was asked of high school students, only 7
percent had never tried regular smokes. That suggests many kids
experiment with the electronic devices and
move on to cigarettes by high school, said CDC Director Dr. Tom Frieden.
"In effect, this is condemning many kids to struggling with a lifelong
addiction to nicotine," he said."

Fortunately, in the same article, there is an opposing quote
from Dr. Kurt Ribisl from the University of North Carolina who pointed
out that the survey results "don't prove that e-cigarettes are a gateway
to smoking cigarettes." However, the CDC's point had already been made.

A quick Google search shows at least 52 different media outlets that
disseminated this information, including the quote indicating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine."

At a recent TMA conference on electronic cigarettes, a CDC official defended Dr. Frieden's statement on the grounds that: (1) It was merely a "slip of the tongue"; and (2) it was inconsequential because very few people saw it.

Apparently, this slip of the tongue, which was disseminated nationwide through more than 50 media outlets, will have no impact on local public health organizations. However, based on today's rest of the story, it appears that this unsupported statement may in fact be leading local public health practitioners to further disseminate this misleading information.

Fortunately, in this case, the misleading information is not supporting a damaging public health policy. However, in other cases, it might well result in a policy that could harm the public's health.

In at least one other case, public health practitioners were explicit in noting that their hypotheses regarding electronic cigarettes and a lifelong addiction to smoking came directly from the CDC. In their op-ed piece published in the Spring Grove (MN) Herald, Shelton (CT) Herald, Los Angeles Daily News, and perhaps other local newspapers, writers from the American Lung Association tell us that: "We share the
CDC's concern that children who begin by using e-cigarettes may be
condemned to a lifelong addiction to nicotine and cigarettes."

Words matter, and the words spoken by the CDC matter even more than those of most health organizations. Many state and local health groups, like the Cambridge Public Health Department, look to the CDC for guidance on health science and policy issues. This is why it is particularly important for the CDC to get it right and not to disseminate false statements that mislead the public.

An associate professor of Pediatrics at the Ohio State University goes so far as to claim that: "a lifelong addiction to nicotine can start with one e-cigarette." We know that this professor relies heavily upon the CDC for his information because earlier in his article he cites the CDC's report on electronic cigarette use among youth. (By the way, he goes on to state: "Even if you assume that e-cigarettes are “cleaner” than tobacco, they
still deliver a potent drug that can lead to lifelong dependence in many
teenagers").

Meanwhile, the CDC's deceptive statements live on.

Just last week, a full eight weeks after the CDC's original statements, they are still being disseminated nationally through the media. An article on electronic cigarettes in Spry, dated November 21, reads: "According to a recent CDC report, the number of high school
students who tried e-cigarettes rose from 4.7% in 2011 to 10% in 2012. In the report, CDC officials expressed concern about the potential
for abuse and addiction inherent in e-cigarettes. “The increased use of
e-cigarettes by teens is deeply troubling,” said CDC Director Tom
Frieden, M.D., M.P.H. “Nicotine is a highly addictive drug. Many teens
who start with e-cigarettes may be condemned to struggling with a
lifelong addiction to nicotine and conventional cigarettes.”"

I believe that it is now the CDC's responsibility to correct its previous statements and to make it clear to state and local public health practitioners that there is no evidence that electronic cigarettes are serving as a gateway to cigarette smoking among young people.

Monday, November 25, 2013

I have previously criticized a CDC statement for implying that electronic cigarettes may be no more harmful than tobacco cigarettes. I quoted the statement as follows: "There is insufficient evidence to determine whether ... electronic cigarettes ... reduce individual ... health risks." "

I have been criticized for not including the full quote, and for not providing the context. So let's now look at the full quote in context.

On the bottom of its web page on low-yield cigarettes, CDC includes a statement about the relative harms of electronic cigarettes compared to smoking. The statement, in full, reads as follows:

In a previous post, I criticized this statement because while I do not think it is unreasonable to question whether electronic cigarettes reduce population health risks, I think it is very clear that electronic cigarettes reduce individual risks. In other words, smokers who switch to electronic cigarettes are reducing their health risks, as these products are much safer than tobacco cigarettes.

Thus, I believe this statement is misleading because it suggests that electronic cigarettes do not reduce either population or individual health risks.

My critique was questioned by an official from CDC, who defended the statement. His argument was that since the sentence says individual AND population health risks, it is accurate, because there is not sufficient evidence to determine if electronic cigarettes reduce BOTH individual and population health risks. But he acknowledged that CDC's position is that a smoker who switches to electronic cigarettes (exclusively) is reducing his or her health risks.

Thus, CDC's position appears to be that while electronic cigarettes can reduce individual health risks, they have not been shown to reduce population health risks.

Instead of stating this, the CDC chose to state that electronic cigarettes have not been shown to reduce BOTH individual and population health risks.

The Rest of the Story

For the sake of argument, let's stipulate that electronic cigarettes do not reduce population health risks, but they can reduce individual health risks. This seems to be consistent with what CDC claims its position is.

Now, it strikes me as rather deceptive (and disingenuous) to inform the public that electronic cigarettes do not reduce individual AND population health risks, when you know that e-cigarettes reduce individual health risks. Why combine both in the same sentence? Why not just state: "While electronic cigarettes can reduce individual health risks, it is not known whether they reduce population health risks."

Perhaps an analogy may help explain this.

Suppose you read the following statement:

"Michael Siegel is not a nice guy and a national hero."

I suppose one could put forth the argument that this statement is technically true. While Michael Siegel is arguably a nice guy, he is most definitely not a national hero.

But this misses the point. Why combine both in the same sentence, unless one's intent is to put into people's mind that Michael Siegel is not a nice guy? (Yes, I realize that we have to stipulate that Michael Siegel is a nice guy for the sake of argument, rather than rely on scientific evidence.)

To further illustrate this point, let's turn the CDC's statement around. What they are essentially asserting is the following:

Technically, this statement may be true because while cigarettes most certainly increase individual health risks, it's not yet clear whether they increase BOTH individual AND population health risks compared to electronic cigarettes.

But do you see how deceptive that statement is?

If a tobacco company were to make that precise statement, anti-smoking groups would certainly attack them. (No - I will not issue another satirical tobacco company press release to make that point; I think we can all accept it is true.)

So if the statement would be very deceptive coming from a tobacco company, how is it not equally deceptive coming from a public health agency?

The final point I want to address is whether this deception is intentional, or simply a careless mistake?

I think I was able to trace the origin of the statement. It comes, word for word, from the 2010 Surgeon General's report. With one exception. The 2010 Surgeon General's report made this statement with regards to tobacco products, meaning products that actually contained tobacco. For example, smokeless tobacco products like Premier, Eclipse, and Accord. But the current statement adds, in parentheses, "e.g., electronic cigarettes."

The statement actually cites the 2010 Surgeon General's report, as if it backs up the assertion that electronic cigarettes do not reduce individual and population risks. But the 2010 report doesn't even mention electronic cigarettes. Is it not deceptive, therefore, to cite a reference that doesn't support the statement being made? Doesn't that make it appear to readers that the Surgeon General's report actually mentioned the topic of electronic cigarettes?

It is just difficult for me to believe that the statement from the Surgeon General's report was "accidentally" revised to include electronic cigarettes. How can that addition be a simple accident, or careless mistake?

If a cigarette company made the same statement ("There is insufficient evidence to determine whether cigarettes increase individual and population
health risks"), would we reasonably conclude that it was just a careless mistake?

Furthermore, one has to consider this in the context of the statements that Dr. Frieden made about electronic cigarettes being a
gateway to youth smoking. It appears to me that CDC is presenting the information to the public with a strong bias. I'm not criticizing this bias, per se, but simply pointing out that the bias appears to be intentional. CDC appears to have a clear position that it wants to articulate to the public.

This could all be corrected and put to an end if CDC simply made a
clarification statement to the public, clearly asserting that electronic
cigarettes are much safer than tobacco cigarettes, and that there is no current
evidence that e-cigarettes are a gateway to smoking. But CDC makes neither of those
statements. In fact, I can’t find a single place where CDC has informed the
public of the truth: that e-cigarettes are much safer than tobacco cigarettes. How am I left to conclude that
this glaring omission is anything but intentional?

But maybe I’m wrong. I keep
waiting to be wrong. But every day I wake up, and there’s no correction from
CDC. No statement about how electronic cigarettes are safer than tobacco
cigarettes.

Believe me, I want nothing more than to find out that this has all been due a simple mistake and that the true intent of the CDC is to impartially provide all of the facts about electronic cigarettes and their relative harms compared to tobacco cigarettes.

Now I go back to the CDC's MMWRarticle about electronic cigarettes. Could I perchance be wrong? Maybe that article mentions that electronic cigarettes are safer than tobacco cigarettes.

No, it doesn't. It does mention that "Potentially harmful constituents ... have been documented in some
e-cigarette cartridges, including irritants, genotoxins, and animal
carcinogens," but it mentions nothing about these products being orders of magnitude safer than tobacco cigarettes. One would think that this would be one of the critical background points made in such an article. Again, this could be a simple omission, but taken in the entire context of the CDC's communications about electronic cigarettes, it is difficult to reach such a conclusion.

I continue to hope that I'm wrong. I guess I’ll just keep waiting.

UPDATE (November 25th, 5:30 pm): The CDC official has assured me that they will be revising the statement by deleting the words "electronic cigarettes" from the sentence. I applaud the CDC for taking the time and effort to correct the statement and for demonstrating a concern for making sure that its communications are not misleading. I am hopeful that this is the first step forward to greater honesty and accuracy in communications from tobacco control organizations. Hopefully, the FDA will be the next to correct its web site.

It appears that there is a sort of double standard in a large segment of today's anti-smoking movement. When the tobacco industry lies to or deceives the public, the industry is worthy of condemnation. But when anti-smoking groups make precisely the same fraudulent statement to the public, it is perfectly acceptable.

Furthermore, if you criticize the tobacco companies for deceiving the public, you are a tobacco control hero. But if you criticize anti-tobacco groups for making the same exact statements, you are a scoundrel and traitor.

H.L. Mencken wrote:

"The truth, indeed, is something that mankind, for some mysterious reason, instinctively dislikes. Every man who tries to tell it is unpopular, and even when, by the sheer strength of his case, he prevails, he is put down as a scoundrel."

Every part of Mencken's quote played out last week.

Indeed, anti-smoking groups do not want to hear the truth: that some of major health and anti-smoking groups are lying to the public about the relative hazards of real (tobacco) vs. fake (electronic) cigarettes. When you point this out, you are indeed unpopular. And even when the strength of your evidence is so strong that the groups realize you are correct, you are then put down as a scoundrel and traitor.

On this very day, the FDA is telling the public that it is not known "if there are any benefits associated with using these products [electronic cigarettes]."

With this statement, the FDA is implying that we don't yet know
whether electronic cigarettes are any safer than tobacco cigarettes.
After all, if these products are safer than cigarettes, then there
certainly is a health benefit associated with using these products
instead of cigarettes, as many vapers are doing.

Thus, the FDA is telling the public that vaping may be no safer than smoking.

We now know for a fact that if a tobacco company were to make precisely the same claim, a number of anti-smoking groups and advocates would condemn those companies. But the very same groups showed no interest when it was the FDA, instead of a tobacco company, that was making that claim. In fact, these groups were ready to pounce on the tobacco company for making a claim that it took directly from the FDA's web site!

However, it is importantto point out that from an ethical perspective, there is no moral principle of which I am aware by which a lie told by a tobacco company is unethical, but a lie told by a health group is ethical. If we are going to hold tobacco companies to the standard of honesty and to be taken seriously doing it, then we ourselves must be at least somewhat honest in our communications with the public, no?

Moreover, it is important to point out that from a public health perspective, undermining the public's appreciation of the harms of smoking does damage, whether it is a tobacco company doing the undermining or a health group.

I have received numerous pleas from my colleagues urging me not to continue to point out false statements being made by anti-smoking groups because it "hurts the cause." Actually, what hurts the cause is groups making false statements. The problem is that many health groups are lying to the public and undermining the public's appreciation of the hazards of smoking, not that some anti-smoking advocate is criticizing these groups and arguing that they should tell the truth, thus attempting to protect the integrity of the tobacco control movement that he has been a part of for the past 28 years.

As H.L. Mencken concluded:

"But the whole thing, after all, may be put very simply. I believe that it is better to tell the truth than to lie. ... And I believe that it is better to know than to be ignorant."

Thursday, November 21, 2013

Like 60 Minutes, the Rest of the Story relied on a source that provided false information. It is not true that any U.S. tobacco company claimed that cigarettes may be no more harmful than electronic cigarettes. It is solely and exclusively public health and anti-smoking agencies and organizations that are making such claims.

In light of this revelation, the Rest of the Story retracts and corrects the final paragraph of that post, changing it from:

"Given the significant amount of damage that could be done because of
this company's public statements, I would hope that public health and
tobacco control organizations would promptly and vigorously attack this
company for making these fraudulent health claims, and demand that it
immediately retract and correct these statements and issue a public
apology.
"

to

"Given the significant amount of damage that could be done because of
the health and anti-smoking groups' public statements, I would hope that public health and
tobacco control organizations would promptly and vigorously attack these agencies and organizations for making these fraudulent health claims, and demand that they
immediately retract and correct these statements and issue a public
apology.
"

The most important thing to every person at the Rest of the Story is the
truth, and today the truth is that we made a mistake. This is a very disappointing situation. We realized that we no longer had confidence in our source. We took the vetting of our source very seriously, but he misled everyone.

We apologize to the tobacco companies for insinuating that one of them was lying to the American public. We reiterate: it was only the public health and anti-smoking groups that were lying, not the tobacco companies.

The Rest of the Story

You can only imagine how disillusioned I am with the current state of affairs in the tobacco control movement. Of course, the post about the tobacco company claiming that electronic cigarettes being no more dangerous than tobacco cigarettes was not true. But it demonstrates how ludicrous the situation in tobacco control is right now. The state of affairs is so ridiculous that when I write about a tobacco company making a false statement to the public, readers are almost uniformly aware that it is a complete joke, but when I write that anti-smoking groups are making precisely the same claim, it is suddenly believable, and in fact, true.

It was quite telling that very soon after my original post, the CDC emailed me wanting to know the name of the tobacco company so that they could "follow up on this as soon as possible." But the statement that apparently offended them was precisely the same statement that CDC makes on its web site! In fact, this fictitious tobacco company was quoting the CDC's statement as supporting evidence for its claim that smoking may be no more hazardous than vaping!

Moreover, why wasn't the CDC interested in following up on the very same fraudulent statements that have been made over the past months by public health organizations and agencies, including the FDA, American Legacy Foundation, American Cancer Society, and American Lung Association?

Apparently, fraudulent statements are only of concern when made by the tobacco companies. The very same statements made by anti-smoking groups are acceptable.

Isn't it time that we start holding ourselves to at least the same standards that we hold the tobacco companies? If we are going to attack the tobacco companies for their dishonesty, shouldn't we be honest ourselves?

Yesterday, a U.S. tobacco company issued a press release claiming that its products may not be any more harmful than electronic cigarettes, citing several government and non-government public health agencies to back up its assertion.

Since it's not clear that electronic cigarettes have killed any vapers, the company argued, it's not clear that tobacco cigarettes are any where near the health threat that they have previously been made out to be. However, the company insisted that the opinion it is expressing is not its own, but that it is merely reiterating what public health officials have stated publicly.

Excerpts from the press release follow:

"Electronic cigarettes are battery-operated devices that heat a solution of nicotine and propylene glycol in order to vaporize the nicotine and deliver it as an aerosol. There is no tobacco in these products, and there is no combustion. Studies have found that the levels of tobacco-specific nitrosamines (a carcinogen) in electronic cigarettes are up to 1,000 times lower than in our products. Nevertheless, numerous public health agencies have declared that our products may not be any more hazardous than using these non-tobacco, non-combustion products that contain only trace levels of tobacco-specific nitrosamines, similar to what one is exposed to in nicotine gum or nicotine patches."

"Reputable public health sources have stated that it is not clear whether cigarette smoking is any more hazardous than electronic cigarette use."

The FDA stated that it is not known "if there are any benefits associated with using these products [electronic cigarettes]."

The FDA also stated that: "There may be a perception that electronic cigarettes...are safer
alternatives to conventional tobacco products. ... However, FDA is not
aware of any scientific data to support those perceptions."

An article by public health researchers from the University of Kentucky states that: "no scientific basis currently exists for making claims of ... reduced harm ... for e-cigarettes."

The American Legacy Foundation stated: "Electronic cigarettes are designed to give you an experience that’s like
smoking but without any smoke. Since they don’t burn tobacco, they’re
marketed as less harmful than regular cigarettes. But so far, there’s no
evidence to prove that claim."

An American Cancer Society official stated: "The truth is, we don’t have the research to
tell us these e-cigarettes are helping people stop smoking or that they
aren’t as dangerous as regular cigarettes. We
just don’t know."

A tobacco expert from the Wake Forest School of Medicine stated: "People perceive them [electronic cigarettes] as safer, but we do not yet know if that is
true."

The American Lung Association stated that: "There is no scientific evidence
that e-cigarettes are safer for consumers than regular tobacco
products."

Researchers from the University of Athens stated: "We do not yet know whether unapproved nicotine delivery products, such
as e-cigarettes, are safer than normal cigarettes, despite marketing
claims that they are less harmful."

An article in the prestigious British Medical Journal concluded: "More rigorous chemical analyses are needed, followed by extensive
research involving animal studies and, finally, clinical trials in
humans. Until these crucial implementation stages are completed,
physicians and other healthcare professionals must inform consumers of
the probable fallaciousness of the claims of manufacturers of
e-cigarettes [that they are safer than tobacco cigarettes]."

"We urge consumers to rely upon these statements of prominent public health agencies, experts, and officials. According to these reputable sources, our products may pose no more risk than electronic cigarettes."

"As a responsible tobacco company, we are committed to providing consumers with accurate health information. We have long acknowledged the dangers inherent in using our products and we are committed to providing information so that consumers can make informed decisions about whether or not to use our products. Given these recent statements of public health officials, it appears that we may have been overly cautious in warning our customers about the hazards of cigarette use. It now appears that our products may be no more harmful than electronic cigarettes. Notably, there have been no reported deaths from electronic cigarettes, despite at least seven years of widespread use. We urge consumers to look to the statements of public health officials and agencies for the most trustworthy guidance on the relative health risks of various consumer products. These officials and agencies have made it clear: our products may compare favorably or equivalent to fake cigarettes that contain no tobacco in terms of health risks. We hope that consumers will take these public health statements into account when making a decision about whether to use our products."

The Rest of the Story

In my opinion, this tobacco company is making a fraudulent health claim. There is abundant evidence that cigarette smoking is much more harmful than vaping. While electronic cigarettes are not "safe" in absolute
terms, there is little question that they are much safer than smoking
tobacco cigarettes. The contention that nicotine plus tens of thousands
of other chemicals including 60 known carcinogens is more dangerous than
nicotine vaporized from a propylene glycol/glycerin solution does not
require rocket science.

The
evidence simply does not support the claim. While cigarette smoke
contains more than 60 carcinogens at relatively high levels, there have
been only three carcinogens found in electronic cigarettes and they are
present only at low levels. In fact, the levels of tobacco-specific nitrosamines (which are present because the nicotine is extracted from
tobacco) are more than 1,000 times lower than those of the same
carcinogens in tobacco cigarettes. Moreover, there are more than 20 laboratory
studies of the constituents of electronic cigarettes and none have
identified any chemicals at levels which would warrant serious concern that vaping poses any where near the level of risk as cigarette smoking.

How
can a tobacco company go out publicly and state that there is no
evidence that electronic cigarettes are any safer than what we already
know is the most dangerous and toxic consumer product on the market,
which we know kills hundreds of thousands of Americans each year? How can this company ignore the available data which clearly show
that the levels of carcinogens in electronic cigarettes are orders of
magnitude lower than in regular cigarettes, and mislead the American public so blatantly?

It seems to me that the Department of Justice should investigate this tobacco company for making fraudulent statements to the American public about the safety of a consumer product. At the very least, public health and tobacco control organizations should expose these fraudulent statements and publicly criticize this company for spreading false information to the public.

The dissemination of this false information is problematic not only because it violates basic ethics, but because it could be damaging to the public's health. The statement that this company is making undermines more than 5 decades of public health efforts to convince the public of the very serious health hazards of cigarette smoking. It is even possible that the company's statement might cause many smokers to continue smoking rather than to quit smoking using a product like electronic cigarettes. It is even possible that this company's statement could cause many ex-smokers who quit using electronic cigarettes to return to cigarette smoking. After all, why continue using electronic cigarettes if they may be just as bad as tobacco cigarettes?

Given the significant amount of damage that could be done because of this company's public statements, I would hope that public health and tobacco control organizations would promptly and vigorously attack this company for making these fraudulent health claims, and demand that it immediately retract and correct these statements and issue a public apology.

Tuesday, November 19, 2013

We tend to think of the FDA and CDC as reliable agencies that we can count on to provide the facts regarding the health risks of cigarette smoking. Today's rest of the story is that this assumption appears to be in doubt after my revelation that both agencies are telling the public that smoking may be no more hazardous than vaping.

With this statement, CDC is implying that we don't yet
know whether electronic cigarettes are any safer than tobacco
cigarettes. After all, if electronic cigarettes were much safer than tobacco cigarettes, then switching from cigarettes to electronic cigarettes would certainly reduce individual health risks. It might not reduce population health risks (e.g., it could hypothetically lead to an increase in smoking), but there's no question that it would reduce individual health risks for smokers who switch to these products.

The FDA tells the public that it is not known "if there are any benefits associated with using these products [electronic cigarettes]."

With this statement, the FDA is also implying that we don't yet know
whether electronic cigarettes are any safer than tobacco cigarettes.
After all, if these products are safer than cigarettes, then there
certainly is a health benefit associated with using these products
instead of cigarettes, as many vapers are doing. Again, there might not be population benefits, but there certainly would be benefits to individual smokers who switch to e-cigarettes.

The Rest of the Story

By implying that we don't know whether electronic cigarettes are any safer than tobacco cigarettes, the FDA and CDC are by definition implying that we don't know whether cigarette smoking is any more hazardous than vaping. In other words, they are not telling the public the truth. They are undermining the public's appreciation of the hazards of cigarette smoking. They are not telling us the full truth about the dangers of smoking.

I don't know whether these agencies realize what they are doing. My sense is that in their zeal to condemn electronic cigarettes, they have lost sight of the bigger picture and have made statements which accidentally undermine the health hazards of smoking.

Fortunately, these statements can be corrected. I hope that both FDA and CDC will correct their false statements and begin to inform the public of the truth about the relative health risks of smoking compared to electronic cigarettes.

Monday, November 18, 2013

Yet another tobacco control practitioner has told the public she is not sure that smoking is any more hazardous than using electronic cigarettes, according to a story from a South Dakota television station.

According to the story: "'I know some of them are being sold as helping you quit tobacco and
some people have used e-cigarettes to quit,' Avera Heart Hospital
Respiratory Therapist Deb Murray said.
But Murray says there's not enough research to prove that e-cigarettes are any better than traditional cigarettes. 'What we know about the e-cigarette is it contains nicotine and some
chemicals, but what we don't know about it is what's the long-term
effect of those chemicals,' Murray said."

The Rest of the Story

I believe it is irresponsible to tell the public (and especially patients) that cigarette smoking may be no more hazardous than vaping. Not only is this blatantly false, but it is damaging because it undermines the public's appreciation of the hazards of smoking and it may even discourage many smokers from quitting.

Ironically, the tobacco companies would never make such a statement, even in an effort to try to protect cigarette sales from dropping due to the increased popularity of electronic cigarettes. So it is indeed ironic that the tobacco companies are telling the truth about this particular scientific issue, and that only anti-smoking advocates are the ones lying about it.

Much of the blame, however, is attributable to some of the major anti-smoking and health groups and agencies, such as the FDA, the CDC, and the American Heart Association, Cancer Society, and Lung Association. Why? Because these agencies and groups have not been telling the public the truth. They have not been informing the public that vaping is much safer than smoking. In some cases, they have been suggesting that smoking may be no more hazardous than vaping.

This certainly suggests to me that the CDC is saying that we don't yet know whether electronic cigarettes are any safer than tobacco cigarettes.

The FDA tells the public that it is not known "if there are any benefits associated with using these products [electronic cigarettes]."

Thus, the FDA appears to be stating quite clearly that we don't yet know whether electronic cigarettes are any safer than tobacco cigarettes. After all, if these products are safer than cigarettes, then there certainly is a health benefit associated with using these products instead of cigarettes, as many vapers are doing.

The American Cancer Society fact sheet about electronic cigarettes fails to inform the public that these devices are safer than tobacco cigarettes.

Likewise, the American Heart Association fact sheet about electronic cigarettes fails to inform the public that these devices are safer than tobacco cigarettes.

Thus, it is no surprise that tobacco control practitioners throughout the country are disseminating false information. The national agencies have misled them, and they are in turn misleading their own constituents.

The rest of the story is that the major anti-smoking groups have essentially conspired to mislead the public about the health effects of electronic cigarettes relative to real tobacco cigarettes. Sadly, this is most likely causing substantial public health damage by undermining the public's appreciation of the hazards of smoking and discouraging many smokers from quitting.

Friday, November 15, 2013

Despite what the CDC has called an alarming increase in electronic cigarette experimentation among youth between 2011 and 2012, the prevalence of cigarette smoking actually declined during the same period, according to a report released by the CDC yesterday.

Among middle school students, current use (at least once in the past 30 days) of electronic cigarettes increased from 0.6% to 1.1% from 2011 to 2012. However, current smoking during the same period declined from 4.3% to 3.5%.

Among high school students, current use of electronic cigarettes increased from 1.5% to 2.8% from 2011
to 2012. However, current smoking during the same period declined from
15.8% to 14.0%.

Of note, this decline in cigarette smoking was not reported in the earlier CDC report on the increase in electronic cigarette use, nor was it mentioned in any of the multitude of interviews or news articles regarding the increase in youth e-cigarette use.

The Rest of the Story

It appears from these data that overall use of electronic cigarettes and conventional cigarettes remained essentially unchanged from 2011 to 2012. Despite the rather drastic increase in e-cigarette use, there was no corresponding increase in smoking. Thus, these data do not provide evidence that e-cigarette use has served as a gateway to smoking.

It may be, for example, that most of the electronic cigarette use that occurred was among either established smokers, or among nonsmokers who would have progressed to become cigarette smokers. This suggests the hypothesis that electronic cigarette availability may actually have prevented some youths from smoking. In other words, it is possible that youths who might otherwise have initiated smoking were instead attracted to electronic cigarettes. This hypothesis appears to be more consistent with the CDC data than its own conclusion that electronic cigarettes are serving as a gateway to youth smoking.

It is concerning to me that the CDC did not report this important finding when it reported its original conclusion that e-cigarette use had drastically increased among youth and that these products were serving as a gateway to smoking. The opportunity to see the data on trends in cigarette smoking would have helped the public to see that there was no scientific support for the CDC's conclusion. I thus find it curious that these important data were not reported until weeks after the media has already disseminated the conclusion that e-cigarettes are a dangerous gateway to cigarette smoking. The CDC officials certainly had plenty of opportunity to let the public know that there was no discernable increase in cigarette smoking among youth concomitant with the observed increase in e-cigarette use. It seems to me that this is a critical finding to report.

My impression remains that there is, for some reason (perhaps related to ideology), a pre-determined conclusion that e-cigarettes are evil. Instead of fairly reporting all of the evidence, only the evidence that supports the pre-determined conclusions are being shared. Data can only support the pre-determined conclusion. No data can refute or conflict with that conclusion.

Thursday, November 14, 2013

In an interview with WebMD, a CDC tobacco control expert concludes that the reason youth are using electronic cigarettes is the advertising of these products.

The CDC official stated: "We don’t like to see kids using any form of nicotine, because nicotine
is not a good thing for a developing adolescent brain. ... It’s
introducing them to a behavior that is very similar to smoking. The
thing that got them interested was mass advertising that glamorizes the
act of vaping."

The Rest of the Story

When I worked at CDC, in the Office on Smoking and Health (OSH), we did not even draw conclusions that cigarette advertising causes youth to initiate smoking without having scientific evidence to support that conclusion. In fact, most of my research at OSH was devoted to study of the relationship between cigarette advertising exposure among youth and adolescent smoking behavior. It would not have occurred to me to conclude that cigarette advertising is the cause of youth smoking in the absence of a single study supporting that conclusion.

Now, however, the CDC is apparently willing to draw a conclusion about the impact of electronic cigarette advertising on youth e-cigarette use without a single study on the topic. To be clear, there is no scientific evidence relating to the impact of e-cigarette advertising on youth vaping. There is not even a single study of the extent of youth exposure to e-cigarette advertising.

Is there a need for research on the potential effect of e-cigarette advertising on youth e-cigarette use? Yesterday, I would have said absolutely. But today, what is the point of doing such research, when a causal conclusion has already been reached and disseminated to the public?

Electronic cigarette advertising levels have not been particularly high and it is not clear how substantial youth exposure to such advertising has been. Another plausible hypothesis is that it is not advertising of the product, but general exposure to the product through the media that has contributed to youth awareness of and experimentation with the product. For all we know, more youth saw Katherine Heigl vape on Letterman than have ever seen a Blu advertisement. (This is a testable hypothesis, by the way, but what is the point of testing it since a conclusion has already been drawn?)

The answer to this important question has significant policy implications. Understanding the reasons for youth vaping, including the potential role of advertising, would be important to the FDA in promulgating regulations that govern e-cigarette advertising.

This appears to be another example of tobacco control practitioners disseminating the answer to a question before we have conducted research to provide an evidence-based answer. Does the answer really matter? It appears not. It appears that a pre-determined ideology that opposes electronic cigarettes is leading us to draw conclusions on the product without evidence. The CDC has already disseminated the conclusions that e-cigarettes are a gateway to youth smoking and that advertising is responsible for this effect, even though there is absolutely no research on either question.

Wednesday, November 13, 2013

Although one would think that the International Union Against Tuberculosis and Lung Disease (the Union) would be against lung disease, one wouldn't know it after reading its recommendation that all advertising and promotion of electronic cigarettes for smoking cessation be banned.

In a position statement on electronic cigarettes, the Union makes the following two recommendations:

(1) a comprehensive ban on all advertising, promotion and sponsorship; and

(2) promotion of ECs/ENDS for tobacco cessation to be prohibited.

These recommendations are based, in part, on the Union's conclusion that electronic cigarettes may be no safer than cigarette smoking (see page 3 of the document).

The Rest of the Story

Why bother with a 29-page, supposedly scientific review of the evidence when you are going to in essence conclude that electronic cigarettes may be no less hazardous than smoking?

The Union warns that the use of electronic cigarettes "is commonly believed by consumers to be safer than smoking tobacco." It then goes on to speak of this relative safety as being "illusive." Thus, it is implying that electronic cigarettes are no safer than smoking.

The Union states: "As ENDS do not generate the smoke that is associated with the combustion of tobacco, their use is commonly believed by consumers to be safer than smoking tobacco. This illusive ‘safety’ of ENDS can be enticing to consumers; however, the chemicals used in electronic cigarettes have not been fully disclosed, and there are no adequate data on their emissions."

Beyond this absurd conclusion, the position statement is disturbing because of its recommendation that advertisements which promote smoking cessation (via the use of electronic cigarettes) be banned. Why ban ads that entice people to quit smoking? I can certainly understand calling on regulation of electronic cigarette advertising to make sure that it does not attract youth, but to ban all electronic cigarette advertising would be a public health disaster, as it would significantly increase the proportion of smokers in the population, and with that, the burden of smoking-related disease and death.

Monday, November 11, 2013

A study in the December issue of Pediatrics reports that an intensive intervention to reduce children's secondhand smoke exposure in households in Armenia decreased exposure by 17% compared to minimal intervention. Based on this finding, the study concludes that the intensive intervention is effective.

The intensive intervention consisted of motivational interviewing and follow-up telephone calls to try to discourage smoking in the household. The minimal intervention consisted of simply providing an educational brochure about the hazards of secondhand smoke exposure. At baseline, all households contained at least one daily smoker and at least one child between the ages of 2 and 6. Child exposure to secondhand smoke was measured by determining hair nicotine concentrations at baseline and at four-month follow-up.

According to the paper, the chief result of the study was as follows: "Multiple linear regression analysis demonstrated that after adjusting for the baseline hair nicotine concentration, child's age, and child's gender, the follow-up GM (geometric mean) of hair nicotine concentration was 17% lower in the intervention group compared with the control group (P = .239)."

The study concludes that: "The results of this trial suggest that adjusted follow-up GM of hair nicotine concentration in the intervention group was 17% lower compared with the control group."

The Rest of the Story

There is an important flaw in this paper which is critical to point out to readers. It is also something that I will use to teach my public health students about common pitfalls in epidemiology and biostatistics and about investigator bias in epidemiologic studies.

Prior to conducting any statistical analysis in an epidemiologic studies, researchers set an a priori level of statistical significance for their findings. Typically, this is set at a level of 5%.

Let us assume that the intervention group is found to have lower exposure than the control group at follow-up. One needs to know whether this finding of decreased exposure is an actual effect of the intervention, or whether is could have occurred simply due to chance. What a 5% level of statistical significance means is that if the findings of the study would have been expected to have occurred by chance alone less than 5% of the time, the result is deemed to be "statistically significant" and one can conclude that there really was a decreased exposure in the intervention group. The probability that the study findings would have occurred by chance alone if there was no true effect is known as the "p-value."

If the p-value is less than 0.05, then the finding is deemed statistically significant. If the p-value is greater than 0.05, then the finding is not statistically significant. What this means is that the finding could have occurred by chance alone and the probability of it occurring by chance alone is higher than the level that the researchers determined in advance they would feel comfortable concluding that the effect is a real one.

In this study, the p-value was 0.239. This means that the findings were not even close to statistical significance. In other words, one cannot conclude that there was any reduction in exposure associated with the intervention. The observation of a lower average exposure level in the intervention group could well have occurred by chance alone.

What all of this means is that it is not correct or appropriate to report that the study found the intervention to be effective in reducing secondhand smoke exposure by 17%. The more appropriate reporting of this finding is that the study failed to find that the intervention had any significant effect on follow-up exposure levels.

In other words, one cannot conclude from this research that the intervention reduced follow-up exposure levels compared to the minimal intervention in the control group.

Interestingly, the paper does note that this key finding was not statistically significant. However, instead of taking the scientifically appropriate action, which is to report that the evidence does not support the conclusion that the intervention reduced exposure, the paper dismissed the lack of statistical significance by arguing that it "could be due to insufficient power, as fewer numbers of families provided hair samples at follow-up."

There are times when one might still conclude that an intervention is effective despite a lack of statistical significance, because of low study power. But this is usually reserved for a situation when the significance level is very close to 0.05. I have never before seen a paper conclude that an effect is real when the observed significance level is as high as 0.24.

In my view, this is a great example of investigator bias influencing the reporting of a result.

Imagine what would happen if every time a result was statistically insignificant, the paper simply dismissed the lack of significance, arguing that the lack of significance was due to low study power. This would undermine scientific research and essentially negate the need to conduct any research in the first place. Why set a pre-determined level of significance if one is simply going to ignore it and conclude that any observed effect is real, regardless of the significiance level?

I can understand the desire to report a positive effect of a public health intervention, especially one designed to protect the health of children. We all want to see our interventions succeed. But in my view, the desire to see an intervention succeed does not justify the dismissal of well-accepted scientific standards to try to show that the intervention is effective.

Incidentally, the paper does the same thing with its examination of whether there was a significant difference in less than daily exposure for children in the intervention group at follow-up, compared to the control group. Using either the mothers' reports or the household smokers' reports, there was no significant difference in less than daily exposure at follow-up (see Table 6 in the paper).

In fact, every analysis in the study of the difference in exposure between the intervention and control group shows no significant difference in exposure.

This doesn't stop the paper from concluding that: "The findings of this study emphasize the importance of motivational interviewing and providing immediate personalized feedback for addictive behavior change."

If that is going to be your conclusion from a study which fails to find any significant difference between the intensive and minimal intervention, then I would argue that there seems to be no point in wasting your time on an evaluation study. Why not just deliver the intervention and don't waste time and money to evaluate it?

After all, if you are going to conclude that the intervention works even if it fails to significantly reduce exposure compared to the minimal intervention, then why bother going through the motions of conducting a statistical analysis?

My greatest concern about this lack of scientific rigor that I repeatedly see cropping up in the tobacco control literature is that it is going to result in a loss of the scientific credibility of the tobacco control movement. If we cannot be trusted to report scientific results objectively in one area of inquiry, then what reason is there to trust us in other areas. We risk not only losing in the effort to convince people that this particular intervention is effective, but in the process we may also lose credibility on the very issue of the harms of secondhand smoke in the first place.

Wednesday, November 06, 2013

Last night, the Beverly Hills City Council failed to adopt a proposed emergency ordinance to place a moratorium on the sale of electronic cigarettes at retail stores in the city. The measure would have required 4 of the 5 council members' votes for adoption but garnered only one vote.

Mayor John Mirisch was quoted as describing his reason for voting against the ordinance as follows: “I can’t see banning e-cigarettes and not cigarettes.” This was precisely the argument I advanced in my blog post yesterday, which I emailed to all five council members.

The Rest of the Story

I applaud the Beverly Hills City Council for making the sensible decision not to remove electronic cigarettes from the market while allowing cigarette sales to continue unchecked. As I argued yesterday, this would have made no public health sense.

One apparent reason for the defeat of the ordinance was the huge turnout of ex-smokers who had quit smoking successfully using electronic cigarettes and spoke passionately about the need to keep this option available for the many smokers who try and fail to quit using "approved" methods (i.e., drugs).

According to Stan Glantz, these people do not exist, as he consistently argues that there are very few people who have quit smoking using electronic cigarettes. But the truth is that not only do these people exist but they are passionate about the product because they have seen firsthand how it can save lives. This is why they turn out in droves when policy makers threaten to ban the product.

While Dr. Glantz might not think these ex-smokers exist, that is not the case for policy makers throughout the country who have considered banning these products.

I applaud the ex-smokers who have quit using electronic cigarettes for having such a presence at hearings such as the one in Beverly Hills last night. Stan might not think they exist, but the policy makers see that they exist.

If this is what ex-smokers who now vape can accomplish without existing, imagine what they can do when they actually are credited with existing.

One of the main criticisms of electronic cigarettes leveled by its opponents in the tobacco control movement is that there are many dual users of e-cigarettes and tobacco cigarettes and that this has adverse public health consequences.

For example, Stan Glantz argued against electronic cigarettes in a Scientific Americanarticle, claiming that: "We’ve found very high levels of dual use [traditional cigarettes along
with e-cigarette use]. Very few people have switched away from
cigarettes or managed to use them as a bridge to eventually go off
cigarettes."

While Dr. Glantz's statement that few people have switched away from cigarettes or used e-cigarettes as a bridge to eventually go off cigarettes was not science-based, but pure speculation, this week a study was published which actually examines the trajectory of electronic cigarette and conventional cigarette use among a cohort of e-cigarette users. For the first time, we are able to examine Glantz's dual use argument and his claim that very few smokers are using e-cigarettes as a bridge to eventually go off cigarettes.

The study examined a cohort of 477 electronic cigarette users who were recruited from e-cigarette and smoking cessation web sites. The cohort was followed for one year, at which time e-cigarette and conventional cigarette use was assessed.

The authors report that among ex-smokers at baseline who had quit smoking using electronic cigarettes and were vaping daily, only 6% relapsed to smoking at 1 year follow-up.

The authors also report that among current smokers at baseline who were vaping daily (i.e., dual users), 46% had quit smoking at 1 year follow-up.

The article concludes that: "Most e-cigarette users were former smokers, who used e-cigarettes much like nicotine medications, to assist quitting, but with a longer duration of use. During the course of one year, use of e-cigarettes was remarkably stable in this group, even in those who had recently started to vape. Among vapers, very few ex-smokers relapsed to smoking, even among recent quitters. Dual users of e-cigarettes and conventional cigarettes reduced their cigarette consumption after they started to vape, and about half had stopped smoking at 1-year follow-up."

The Rest of the Story

It is first essential to point out that these results are not generalizable to the overall population. This is a select group of electronic cigarette users who were particularly committed to these products. The results apply to a select group of users who were vaping daily.

Nevertheless, the results do demonstrate that in contrast to the claims of many anti-smoking advocates, dual use of electronic cigarettes and conventional cigarettes does not necessarily have adverse public health consequences. Instead, it appears that for many smokers, dual use serves as a gateway to smoking cessation.

These results should not be used to make claims about the overall effectiveness of e-cigarettes in the population (for example, we cannot infer that 46% of all dual users will quit smoking). And clearly, research is necessary to estimate the corresponding percentages of changes in smoking behavior among a cohort of smokers that is representative of the overall population.

However, the results of this study suggest that anti-smoking advocates such as Dr. Glantz are wrong in asserting that very few smokers "have switched away from
cigarettes or managed to use them as a bridge to eventually go off
cigarettes." Instead, there appears to be a large number of smokers who have indeed switched completely from smoking to vaping, and there also appears to be a large number of smokers who have successfully used electronic cigarettes as a bridge to complete smoking cessation.

Dual use is not necessarily a bad thing. In fact, it may for some be a gateway to smoking cessation.

Tuesday, November 05, 2013

Tonight, the Beverly Hills City Council is considering an ordinance that would place a moratorium on the sale of electronic cigarettes because of hypothetical health concerns, while allowing the known toxic tobacco cigarettes to continue to be sold. While the ordinance directs the city to study the health effects of electronic cigarettes, there is no similar directive to study the health effects of tobacco cigarettes.

Specifically, the ordinance would place a 45-day moratorium on the sale of electronic cigarettes (stores would be allowed to sell their existing supply for the next two weeks). The ordinance would take effect immediately upon adoption, and the moratorium could be extended for up to 10 1/2 months. The ordinance affects all retail sales of electronic cigarettes in Beverly Hills.

The measure is being considered as an interim urgency ordinance. This is intended to address an urgent situation. The ordinance would go into effect immediately. It does require a four-fifths majority vote of the Council to be adopted.

The Rest of the Story

Can someone help me to understand the rationality of enacting a moratorium on the sale of electronic (i.e., fake) cigarettes while allowing the real ones to remain on the market.

If the Beverly Hills City Council were really interested in protecting the public's health, it would issue an emergency ordinance banning the sale of tobacco cigarettes. After all, cigarette smoke is known to contain more than 10,000 chemicals, including 60 known human carcinogens and smoking kills more than 400,000 Americans each year. In contrast, electronic cigarettes contain only a few chemicals and have not been shown to kill anyone. In fact, other than mild respiratory irritation, there are no known adverse health effects of electronic cigarettes.

So what sense does it make to ban the sale of electronic cigarettes while allowing Beverly Hills residents to continue to buy the real thing? From a public health perspective, this is one of the most inane proposed public policies I have seen in a long time.

To be sure, this policy - if adopted - will result in public health harm. Specifically, it will undoubtedly make it more difficult for many ex-smokers in Beverly Hills to obtain electronic cigarettes and will essentially force them to return to cigarette smoking. Many of the residents who purchase their electronic cigarettes at stores in Beverly Hills undoubtedly use these products to keep them off regular tobacco cigarettes. For these individuals, the removal of e-cigarettes from the market places them at great risk of returning to cigarette smoking. How exactly, then, does this ordinance protect the public's health?

While it is true that more research is necessary to characterize the absolute risk profile of electronic cigarettes, there is no doubt that these products are much safer than tobacco cigarettes. And while there are concerns about quality control issues, the FDA is about to announce (perhaps within days) proposed regulations to help ensure the quality and safety of these products.

The benefits of electronic cigarettes are clear: they help many smokers to quit smoking. They are especially advantageous to smokers who have failed to quit using traditional methods. Taking these products off the market is essentially condemning many smokers to continued smoking by taking away a viable option for them to try to kick the addiction.

In contrast to the known benefits, the risks are - so far - hypothetical. It is possible that these products may serve as a gateway to youth smoking, but there is no evidence that this is occurring and the first published study to examine this question provided evidence that it is not occurring. It is also possible that these products could inhibit smokers from quitting. However, the existing evidence suggests the opposite: that smokers using this product are not people who would otherwise quit smoking. Instead, these products appear to help many smokers quit who were unable to quit using other methods.

I certainly hope that rational minds prevail and that at least 2 of the Beverly Hills City Councilmembers vote against adopting this emergency moratorium against selling a product that is helping many city residents to get off of deadly cigarettes. Banning the sale of electronic cigarettes while allowing the sale of the real ones would set a terrible public health policy precedent.

While cigarette smoke contains more than 10,000 chemicals, including more than 60 known human carcinogens, and is known to kill more than 400,000 Americans each year, a professor of nursing who is a tobacco control practitioner at the University of Virginia is telling the public that smoking is no more dangerous than using electronic cigarettes, which contain no tobacco, involve no combustion, and deliver nicotine without the tens of thousands of chemicals in tobacco smoke.

In an op-ed published yesterday in the Daily Progress (Charlottesville, VA), a professor of nursing at the University of Virginia argued that: "What we don’t know is the science as to whether e-cigarettes are a safer
alternative or just more of the same. As a professional nurse, I wager
the latter."

The Rest of the Story

As a professional nurse, I don't think she should be wagering. Especially because this is a particularly bad bet.

If you want to put money down on which is safer, why would you choose a product that we know kills hundreds of thousands of Americans each year over a product which has not yet been shown to have any serious adverse health effects? Why would you choose a product which delivers nicotine plus tens of thousands of chemicals and more than 60 carcinogens over one which delivers nicotine with just a few chemicals and low levels of only a few of the carcinogens in tobacco smoke? Why would you pick the product which has been shown to cause acute endothelial dysfunction over the one which does not appear to have acute effects on the coronary circulation? Why would you wager on the one which is known to acutely impair lung function over the one which actually improves lung function among smokers who switch to it?

What is particularly disturbing to me is that this is a nurse providing medical advice to potentially thousands of readers and she misleads them into thinking that vaping is every bit as dangerous as smoking. This undermining of the public's appreciation of the serious hazards of cigarette smoking is, in my mind, public health malpractice. If the tobacco companies were to make the same argument, we would attack them for committing fraud.

Beyond this fraudulent statement, there are numerous other misrepresentations in the piece. First, she insinuates that electronic cigarettes cannot be used to help smokers quit:

"The American Lung Association is very concerned about the potential
health consequences of electronic cigarettes, as well as claims that
they can be used to help smokers quit."

There is no argument over whether electronic cigarettes can help smokers quit. They have been documented to have helped many smokers quit. Many testimonials as well as a number of surveys, focus groups, and at least two clinical trials have documented that electronic cigarettes can indeed help some smokers quit. We don't know the exact proportion of smokers who will quit after trying electronic cigarettes, but to claim that they cannot be used to help smokers quit is false.

Second, while she attacks electronic cigarettes because they contain tobacco-specific nitrosamines, she fails to tell readers the rest of the story: that nicotine patches and nicotine gum also contain tobacco-specific nitrosamines. In fact, there are only trace levels of tobacco-specific nitrosamines in electronic cigarettes and these levels are comparable to those in FDA-approved nicotine replacement products.

Third, while she tells readers that one brand of e-cigarettes was found to contain diethylene glycol in a test four years ago, she fails to inform readers that subsequent to that, there have been no reports of any electronic cigarette brands that tested positive for diethylene glycol. This hasn't stopped the Mayo Clinic from calling e-cigarettes a "cousin to anti-freeze" and it doesn't stop the author of the op-ed from trying to scare the public into thinking that using electronic cigarettes is like exposing oneself to anti-freeze.

Finally, she misleads readers into believing that electronic cigarettes deliver the same poisons as tobacco cigarettes, which is not true. She writes: "E-cigarettes might seem to tout a pathway to tobacco-less freedom, but
they entangle individuals in the same poisons as their smoke-filled
grandfathers."

It is getting to the point where not a day goes by without a tobacco control practitioner disseminating false information about electronic cigarettes. This troubles me for two reasons. First, it is damaging to the public's health. It discourages smokers from quitting (using electronic cigarettes) and it may even stimulate some former smokers (who already quit using electronic cigarettes) to resume smoking. In fact, what advantage is there to remaining an ex-smoker if electronic cigarettes contain the same poisons as cigarettes. You might as well go back to smoking.

Second, I think that these repeated and sustained fraudulent statements are damaging the credibility of the tobacco control movement. If we in public health cannot be trusted to provide accurate information about health risks, then who can?

Monday, November 04, 2013

Several weeks ago, I reported that CDC Director Dr. Thomas Frieden stated that many youth have become cigarette smokers because they
experimented with electronic cigarettes, which then led to their smoking
initiation.

"What we are doing first is tracking, and we are seeing some very
concerning trends. Use of e-cigarettes in youth doubled just in the past
year, and many kids are starting out with e-cigarettes and then going
on to smoke conventional cigarettes."

I argued that: "This statement, sadly, appears to be a fabrication. The CDC survey did not show that many youth smokers actually started with e-cigarettes. In fact, the survey did not even assess that question. It measured the prevalence of smoking and electronic cigarette use among youth, but it was a cross-sectional survey and it did not track youth over time to determine their vaping and smoking patterns. Moreover, it did not collect complete smoking and vaping histories from the youth so that it could answer this question. In other words, Dr. Frieden apparently just fabricated this evidence and presented it as being a result of the CDC's surveillance of youth e-cigarette use."

Last week, I presented these facts at the TMA conference on electronic cigarettes. A CDC official defended Dr. Frieden's statement on three grounds:

First, it was merely a "slip of the tongue."

Second, it was inconsequential because very few people saw it.

Third, it is only one minor sentence out of a much longer and more detailed presentation of the survey results.

The Rest of the Story

It is difficult to see how this could merely be a slip of the tongue because it appears to be a pretty well thought-out statement that depicts a complex sequence of events. I have a hard time seeing how a statement that youth are starting with e-cigarettes and then going on to smoke tobacco cigarettes is merely a slip of the tongue. The CDC survey did not address this issue and it seems hard to believe that adding this as a conclusion of the CDC study simply "slipped out."

Moreover, this was a live interview, not a reporter editing together sound bites. So if it had been a slip of the tongue, Dr. Frieden could easily and immediately have corrected it. Once it "slipped out," he could easily have just corrected the statement and explained that the survey actually did not find that electronic cigarettes are serving as a gateway to smoking and that it didn't actually assess that question.

Furthermore, even if we assume that it was a slip of the tongue and that the mistake wasn't noticed at the time, it could have been corrected afterwards, once the video and transcript were published online. I have no doubt that Medscape would post a corrective statement.

The argument that this is inconsequential because very few people saw the statement is refuted by data on the popularity of the Medscape web site. According to Alexa, which monitors the popularity of web sites, Medscape is among the top 2,000 most viewed web sites in the United States. It appears that even in its early years, Medscape had over 1,000,000 members, "far exceeding the reach of any medical journal in history and most consumer publications."

Moreover, the idea that the CDC would downplay a factual misstatement because the media outlet is inconsequential doesn't hit me right (and seems to be somewhat of an insult to Medscape).

The third argument - that this is just one minor sentence somehow taken out of a larger context - ignores the way in which public health advocates and policy makers are influenced by the media. A single conclusion by a prominent health official in the media is enough to influence the knowledge, conclusions, and positions of health organizations and policy makers for years. For example, the FDA's misleading insinuation back in 2009 that electronic cigarettes contain "anti-freeze" is still widely quoted by public health groups and policy makers to this day, and it has undoubtedly influenced public policy on this issue.

Words matter, especially when they come from the head of such a distinguished and respected organization like the CDC.

Moreover, the CDC statement is not taken out of context or extracted as a minor sentence from a larger presentation of the study results. In fact, I included the entire quotation of Dr. Frieden's comments regarding the conclusion of the CDC survey. The entirety of his presentation of the study results in the interview was as follows: "What we are doing first is tracking, and we are seeing some very
concerning trends. Use of e-cigarettes in youth doubled just in the past
year, and many kids are starting out with e-cigarettes and then going
on to smoke conventional cigarettes." I don't see how or why we should simply ignore that statement and pretend that it doesn't exist (especially when the statement is still on the web site, still being viewed by readers, and hasn't been corrected).
But that's not the whole rest of the story.

The rest of the story is that CDC has in at least two other media interviews presented the gateway hypothesis as a definitive conclusion of its survey.

First, in a widely circulated Associated Pressstory, which appeared in numerous newspapers and on television station sites, Dr. Frieden was quoted as stating that electronic cigarettes are "condemning many kids to struggling with a lifelong addiction to nicotine." These articles also state that Dr. Frieden suggested the CDC survey data indicate that many kids experiment with e-cigarettes and then go on to smoke cigarettes.

According to the AP story: "But health officials worry e-cigarettes could re-ignite teen
cigarette use. They point to a finding in the study that 20 percent of
middle school e-cigarette users had never tried conventional cigarettes.
When the same question was asked of high school students, only 7
percent had never tried regular smokes. That suggests many kids experiment with the electronic devices and
move on to cigarettes by high school, said CDC Director Dr. Tom Frieden. "In effect, this is condemning many kids to struggling with a lifelong addiction to nicotine," he said."

Fortunately, Mike Stobbe also included in his article an opposing quote from Dr. Kurt Ribisl from the University of North Carolina who pointed out that the survey results "don't prove that e-cigarettes are a gateway to smoking cigarettes."

A quick Google search shows at least 52 different media outlets that disseminated this information. Was this statement, that e-cigarettes are condemning kids to a lifetime of addiction, also just a slip of the tongue? And is it also inconsequential? Is this just another minor public statement that is being taken out of context?

Second, in a CNN interview, Dr. Frieden concluded that while the reported benefits of electronic cigarettes -- aiding smoking cessation -- are merely "possible," the speculated and undocumented potential harms -- such as hooking kids to smoking -- are "definite":

"I think what we can say basically is they might or might not be able
to help you quit, but there are definite harms that they can cause. And
those definite harms are in different environments. So, if
they get kids hooked on nicotine, that's a really bad thing. If they get
a smoker who would have quit smoking to continue smoking, that's a bad
thing. If they get a smoker who stopped mo smoking and going back to
nicotine addiction and then smoking, that's a bad thing. And if they
re-glamorize the act of smoking, that's a bad thing. So, we have possible benefits and definite harms."

Here, it is hard to imagine that this is merely a slip of the tongue. Dr. Frieden appears to go out of his way to emphasize that the potential benefits of electronic cigarettes are just speculative, but that the potential harms are definite. In other words, we don't have scientific evidence to support the conclusion that e-cigarettes can help people quit smoking, but we do have evidence that they contribute to increased smoking.

Taken together, I simply don't see any support for the argument that these statements are all just slips of the tongue that are inconsequential because very few people are seeing them and that they are minor statements that have been inappropriately extracted out of context.

Instead, it appears to me that the CDC's intention was to infer to the public that there is now scientific evidence that electronic cigarettes are causing societal harm by helping to hook youth on nicotine and push them into a lifetime of smoking. In fact, I think CDC did a great job of making this point and I don't see how it would have been accomplished any better had there actually been a study documenting that a substantial proportion of nonsmoking youth are becoming addicted to nicotine and then progressing to cigarette smoking.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.